Baclofen

Product NDC
50090-0564
11-digit product format
500900564
Labeler code
50090
Product ID
50090-0564_cee85db5-a84f-48c3-9c5c-e2a4b8af718d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA072234
Marketing category
ANDA
Marketing start
1988-07-21
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
10 mg/1
Pharmacologic classes
GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0564-0Baclofen60 in 1 BOTTLETABLET6010
50090-0564-1Baclofen30 in 1 BOTTLETABLET3010
50090-0564-3Baclofen90 in 1 BOTTLETABLET9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0564BACLOFEN TABLET [A-S MEDICATION SOLUTIONS]10Legacy NDC, 3 package rows20210616_36f8b9c9-4e9d-41e4-b889-05cb948c6718.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN36f8b9c9-4e9d-41e4-b889-05cb948c671810
197391baclofen 10 MG Oral TabletSCD36f8b9c9-4e9d-41e4-b889-05cb948c671810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0564-05009005640060 TABLET in 1 BOTTLE (50090-0564-0) 60 tablet2016-06-290000-00-00NoNoCurrent
50090-0564-15009005640130 TABLET in 1 BOTTLE (50090-0564-1) 30 tablet2016-06-290000-00-00NoNoCurrent
50090-0564-35009005640390 TABLET in 1 BOTTLE (50090-0564-3) 90 tablet2016-06-290000-00-00NoNoCurrent